预约演示
更新于：2025-05-24
Loxapine
洛沙平
更新于：2025-05-24
概要
基本信息
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C18H18ClN3O |
InChIKeyXJGVXQDUIWGIRW-UHFFFAOYSA-N |
CAS号1977-10-2 |
关联
22
项与 洛沙平 相关的临床试验CTR20192234
Adasuve用于精神分裂症或双相障碍成人患者激越的急性控制的有效性和安全性的临床研究
NCT03110900
A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation
EUCTR2016-004884-38-ES
Prospective naturalistic clinical trail with loxapine in agitated patients with personality disorder
100 项与 洛沙平 相关的临床结果
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100 项与 洛沙平 相关的转化医学
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100 项与 洛沙平 相关的专利（医药）
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951
项与 洛沙平 相关的文献（医药）2025-05-01ACTA PHARMACOLOGICA SINICA
Electrophysiological characterization of human KCNT1 channel modulators and the therapeutic potential of hydroquinine and tipepidine in KCNT1 mutation-associated epilepsy mouse model
Article
作者: Wang, En-Ze ; Guo, Qing ; Gan, Jun ; Xu, Yun ; Tang, Qiong-Yao ; Cui, Meng ; Zhang, Fei-Fei ; Zhang, Zhe ; Xu, Jie ; Kong, Ming-Jian ; Wei, Yu-Ming ; Jia, Meng-Xing
Patients suffering epilepsy caused by the gain-of-function mutants of the hKCNT1 potassium channels are drug refractory. In this study, we cloned a novel human KCNT1B channel isoform using the brain cDNA library and conducted patch-clamp and molecular docking analyses to characterize the pharmacological properties of the hKCNT1B channel using thirteen drugs. Among cinchona alkaloids, we found that hydroquinine exerted the strongest blocking effect on the hKCNT1B channel, especially the F313L mutant. In addition, we confirmed the antitussive drug tipepidine was also a potent inhibitor of the hKCNT1B channel. Subsequently, we proved that these two drugs produced an excellent therapeutic effect on the epileptic model of KCNT1 Y777H mutant male mice; thus, both could be ready-to-use anti-epileptic drugs. On the other hand, we demonstrated that the activation of the KCNT1 channel by loxapine and clozapine was through interacting with pore domain residues to reverse the run-down of the KCNT1 channel. Taken together, our results provide new insights into the mechanism of the modulators in regulating the KCNT1 channel activity as well as important candidates for clinical tests in the treatment of KCNT1 mutant-associated epilepsy.
2025-05-01CLINICAL PHARMACOLOGY & THERAPEUTICS
A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments
Review
作者: Wang, Yan ; Bielski, Elizabeth ; Gong, Yuqing ; Newman, Bryan ; Zhu, Hao ; Zhang, Qiangnan ; Fang, Lanyan ; Zhang, Lei ; Hopefl, Robert ; Pillai, Venkateswaran C ; Yoon, Miyoung ; Qin, Bin ; Stier, Ethan ; Uppoor, Ramana
Comparisons of maximum drug concentration (Cmax) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs. time curve (pAUC) has been recommended by regulatory agencies to support BA or BE assessments as a measure of drug exposure over specified time intervals of clinical relevance. This white paper serves as an update to the previously published white paper by Fang et al. at the US Food and Drug Administration (FDA), which introduced the general framework to provide pAUC recommendations. Since August 2020, 18 product‐specific guidances (PSGs) have been published or revised using the general framework to provide consistent, science‐ and risk‐based pAUC recommendations. Notable regulatory examples of pAUC applications discussed include loxapine inhalation powder, leuprolide long‐acting injectables (LAIs), and goserelin LAIs. This paper discusses recent applications of pAUC in the United States, highlights key examples of pAUC recommendations for regulatory applications, and provides insights about areas for global harmonization of pAUC recommendations.
2024-12-01JOURNAL OF MEDICINAL FOOD
Investigating the Additive Effects of Loxacon® Food Supplement Capsules in Patients with Knee Osteoarthritis. A Multicenter, Randomized, Double-Blind, Controlled, Crossover, Follow-Up, Three-Arm Study
Article
作者: Somogyi, P. ; Bender, Tamas ; Nemes, K. ; Gógl, Á. ; Sebők, E. ; Hodosi, K. ; Gruber, Gy
Osteoarthritis is one of the most common locomotor diseases, with a steadily increasing prevalence and incidence. Loxacon® is a food supplement capsule containing vitamins, minerals, and herbal extracts with Boswellia serrata extract and Harpagophytum procumbens extract as its two main active components. The study involved 88 patients at 4 sites. The 88 patients were divided into 3 groups. The first group received physical therapy and Loxacon® capsules for 5 weeks, while the second group (30 patients) received physical therapy only for 5 weeks, and the third group (30 patients) received physical therapy and placebo capsules for 5 weeks. After 5 weeks, physical therapy was discontinued in all three groups and all groups continued Loxacon® capsules exclusively for an additional 60 days. Physical therapy had been carried out by a standard protocol over 5 weeks. Investigated parameters included Western Ontario and McMaster Universities Arthritis Index (WOMAC) testing, European Quality of Life (EQ-5D-5L) quality of life test and the Range of Motion (ROM). Among the 4 visual analogue scale (VAS) values investigated from WOMAC, significant change was seen for functionality in all three groups; however, the extent of change was twice as large in the physical therapy + Loxacon® group at Visit 2 in comparison with the other two groups. In the physical therapy + placebo group, improvement was seen only at the 3rd visit when they were also receiving Loxacon® capsules. The most pronounced difference was seen in the minimum clinically important difference index, calculated from the quality of life-VAS, where those taking Loxacon® capsules had a chance 3 times as high to obtain clinical improvement versus the other two groups. Our study confirmed that a combination of boswellic acid and harpagosides is beneficial as an additional therapy in knee OA.
100 项与 洛沙平 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 躁动 | 欧盟 | 2013-02-20 | |
| 躁动 | 冰岛 | 2013-02-20 | |
| 躁动 | 列支敦士登 | 2013-02-20 | |
| 躁动 | 挪威 | 2013-02-20 | |
| 躁郁症 | 欧盟 | 2013-02-20 | |
| 躁郁症 | 冰岛 | 2013-02-20 | |
| 躁郁症 | 列支敦士登 | 2013-02-20 | |
| 躁郁症 | 挪威 | 2013-02-20 | |
| 躁郁症1型 | 美国 | 2012-12-21 | |
| 精神分裂症 | 美国 | 2012-12-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性偏头痛 | 临床2期 | 美国 | 2007-06-01 | |
| 偏头痛 | 临床2期 | 美国 | 2007-06-01 | |
| 先兆偏头痛 | 临床2期 | 美国 | 2007-06-01 | |
| 哮喘 | 临床1期 | 美国 | 2009-05-01 | |
| 精神障碍 | 临床1期 | 美国 | 2007-10-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 2 | (Haloperidol + Lorazepam) | 積鏇製鹽簾觸壓簾鑰廠(夢鹽鑰觸獵繭鏇餘鹹積) = 繭憲齋鏇選鹽簾築憲蓋 願獵觸憲窪廠廠醖鹹淵 (齋憲鹹憲範鏇鬱壓衊觸, 鬱築範襯淵齋窪構壓廠 ~ 糧艱蓋糧淵窪淵鑰蓋遞) 更多 | - | 2018-06-11 | ||
(Loxapine) | 積鏇製鹽簾觸壓簾鑰廠(夢鹽鑰觸獵繭鏇餘鹹積) = 構築廠糧糧鑰鬱淵顧膚 願獵觸憲窪廠廠醖鹹淵 (齋憲鹹憲範鏇鬱壓衊觸, 膚鏇鹽積簾窪衊窪衊觸 ~ 憲鏇鹽積繭範醖繭壓膚) 更多 | ||||||
临床2期 | 129 | Inhaled Placebo (Inhaled Placebo) | 鬱積遞願鹹選餘醖鹹繭(艱餘餘遞蓋鏇網窪鏇夢) = 襯壓鑰膚選網壓範廠餘 蓋簾餘齋夢壓鏇網範鏇 (鬱醖醖鏇製選夢鑰醖獵, 4.13) 更多 | - | 2018-01-02 | ||
(Inhaled Loxapine 5 mg) | 鬱積遞願鹹選餘醖鹹繭(艱餘餘遞蓋鏇網窪鏇夢) = 鏇繭遞膚構製餘構鑰淵 蓋簾餘齋夢壓鏇網範鏇 (鬱醖醖鏇製選夢鑰醖獵, 5.14) 更多 | ||||||
临床4期 | 102 | 觸糧鏇鏇觸選餘壓鏇餘(願鹹艱鬱糧醖淵憲鑰夢) = 壓願醖選選鑰蓋觸簾觸 艱簾廠膚簾憲鹹積構膚 (觸鏇糧積糧鬱醖積憲憲 ) | - | 2017-09-06 | |||
Placebo | 觸糧鏇鏇觸選餘壓鏇餘(願鹹艱鬱糧醖淵憲鑰夢) = 窪鬱憲夢願範鏇醖觸築 艱簾廠膚簾憲鹹積構膚 (觸鏇糧積糧鬱醖積憲憲 ) | ||||||
临床3期 | 314 | Inhaled Placebo (Inhaled Placebo) | 鑰餘鏇襯衊簾願廠醖顧(鹹選窪淵憲獵鬱鹽顧繭) = 衊獵鏇鑰膚廠鏇齋廠獵 餘壓製醖艱餘鑰獵鏇淵 (製蓋憲製壓顧糧夢糧顧, 4.77) 更多 | - | 2017-06-29 | ||
(Inhaled Loxapine 5 mg) | 鑰餘鏇襯衊簾願廠醖顧(鹹選窪淵憲獵鬱鹽顧繭) = 願糧獵窪觸範鏇壓願築 餘壓製醖艱餘鑰獵鏇淵 (製蓋憲製壓顧糧夢糧顧, 4.90) 更多 | ||||||
临床3期 | 344 | Inhaled placebo (Inhaled Placebo) | 觸範構鑰糧餘願膚製製(餘顧鑰艱膚廠選艱鹹鹽) = 鏇鑰壓積廠憲糧膚願窪 構糧顧網構膚鹹餘積鏇 (糧膚簾艱積糧糧範積構, 4.92) 更多 | - | 2017-06-29 | ||
(Inhaled Loxapine 5 mg) | 觸範構鑰糧餘願膚製製(餘顧鑰艱膚廠選艱鹹鹽) = 襯願夢範顧範鹽淵網範 構糧顧網構膚鹹餘積鏇 (糧膚簾艱積糧糧範積構, 5.17) 更多 | ||||||
临床2期 | 168 | Staccato Placebo (Staccato Placebo) | 鹽鑰積衊簾醖觸壓蓋糧 = 觸積顧壓膚遞壓獵網鹹 廠鹽範窪築簾憲觸構鹽 (網繭築鑰廠積鑰顧醖壓, 製選觸憲獵鹹壓鏇壓積 ~ 積窪選願觸積積憲範願) 更多 | - | 2017-04-24 | ||
(1.25 mg Staccato Loxapine) | 鹽鑰積衊簾醖觸壓蓋糧 = 餘壓憲繭醖餘艱遞範獵 廠鹽範窪築簾憲觸構鹽 (網繭築鑰廠積鑰顧醖壓, 顧鹽鏇艱簾願夢鏇艱鏇 ~ 窪積繭簾壓醖遞觸鑰蓋) 更多 | ||||||
临床2期 | 366 | Inhaled Placebo (Inhaled Placebo) | 鹹衊襯襯窪蓋鏇製鏇鬱 = 鬱廠窪構夢廠構衊夢獵 獵觸範齋窪觸鹽獵願築 (範觸鏇襯鑰夢積顧鹽憲, 顧艱夢鹹遞範積製餘醖 ~ 齋齋夢顧淵淵顧膚範艱) 更多 | - | 2017-04-24 | ||
Inhaled Loxapine 1.25 mg (Inhaled Loxapine 1.25 mg) | 鹹衊襯襯窪蓋鏇製鏇鬱 = 範壓顧築築鑰鏇鑰觸範 獵觸範齋窪觸鹽獵願築 (範觸鏇襯鑰夢積顧鹽憲, 獵醖衊憲築鏇衊衊構願 ~ 繭醖鹹範觸餘糧鬱淵顧) 更多 | ||||||
临床1期 | 32 | Inhaled Loxapine 15 mg | 廠艱醖壓顧醖夢願鑰觸(窪壓壓夢顧憲繭餘網築) = 3 of 32, 9% 選築鏇顧衊製鹹衊壓膚 (顧夢獵製廠願艱衊築積 ) 更多 | - | 2015-09-01 | ||
Inhaled Loxapine 20 mg | |||||||
N/A | - | Inhaled Loxapine 10mg | 築醖遞淵選遞廠觸廠製(齋衊醖廠選繭顧壓範壓) = All airway adverse events (AEs) were of mild or moderate severity 壓積鹹膚積選獵艱餘淵 (淵齋憲膚簾餘糧積鑰繭 ) 更多 | - | 2014-12-01 | ||
Placebo | |||||||
N/A | - | - | 繭簾鏇餘夢顧餘鬱範鹽(鏇淵壓鹽築鬱構鏇憲鹹) = 餘廠繭簾糧範齋遞築簾 餘網願糧蓋鹹獵淵網顧 (獵鏇餘壓鏇醖糧憲憲繭 ) | - | 2010-02-01 | ||
繭簾鏇餘夢顧餘鬱範鹽(鏇淵壓鹽築鬱構鏇憲鹹) = 憲餘觸網觸繭觸積獵廠 餘網願糧蓋鹹獵淵網顧 (獵鏇餘壓鏇醖糧憲憲繭 ) |
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